TriangleNCT01953692 · OUTCOME
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Negative Participants in Cohort 1: Myelodysplastic Syndrome (MDS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Up to approximately 78.5 months
What was measured
ORR was defined as the percentage of participants with response (complete response \[CR\] or partial response \[PR\]) according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. CR was demonstrated by ≤5% myeloblasts with normal maturation of all cell lines in the bone marrow (persistent dysplasia will be noted) and normal findings for hemoglobin, platelet count, neutrophil count, and absence of blasts in the blood. PR was all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pre-treatment but still \>5%. Cellularity and morphology are not relevant. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 negative (PD-L1 of \<1%) participants.
Analysis population: All participants in Cohort 1, who were PD-L1 negative, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. ORR by PD-L1 status was not analyzed because there were no participants who demonstrated a PR or CR in Cohort 1.
Groups in this outcome
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
| Group | Source count |
|---|---|
| Cohort 1: Myelodysplastic Syndrome (MDS) | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- ORR was defined as the percentage of participants with response (complete response \[CR\] or partial response \[PR\]) according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. CR was demonstrated by ≤5% myeloblasts with normal maturation of all cell lines in the bone marrow (persistent dysplasia will be noted) and normal findings for hemoglobin, platelet count, neutrophil count, and absence of blasts in the blood. PR was all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pre-treatment but still \>5%. Cellularity and morphology are not relevant. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 negative (PD-L1 of \<1%) participants.
- groups
- description
- Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
- id
- OG000
- title
- Cohort 1: Myelodysplastic Syndrome (MDS)
- population Description
- All participants in Cohort 1, who were PD-L1 negative, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. ORR by PD-L1 status was not analyzed because there were no participants who demonstrated a PR or CR in Cohort 1.
- reporting Status
- POSTED
- time Frame
- Up to approximately 78.5 months
- title
- Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Negative Participants in Cohort 1: Myelodysplastic Syndrome (MDS)
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice